Sanofi-aventis continues case over Lovenox

Sanofi-aventis is to continue its legal battle against the US FDA in relation to a generic version of Lovenox, despite rejection for preliminary injunctive relief

Sanofi-aventis (S-A) has announced it will continue its legal battle against the US Food and Drug Administration (FDA) in relation to a generic version of its blood-clot drug Lovenox, despite the US District Court of Colombia denying S-A's request for preliminary injunctive relief against the FDA.

A federal judge has denied S-A's request to issue preliminary injunctive relief against the FDA, which would have prevented the sale of generic versions of the company's anticoagulant Lovenox (enoxaparin) until a final verdict is delivered in S-A's case against the FDA over whether the body should have issued an abbreviated new drug application (ANDA) to Sandoz and Momenta for a generic version of Lovenox in July.

However, in a statement, S-A said it would continue its case against the FDA without preliminary injunctive relief, believing it still has a case relating to the FDA's review process for complex pharmaceutical products.

According to S-A, Lovenox has a highly-complex biological make-up and its structure, pharmacological properties and clinical properties are highly dependent on the manufacturing process, making it very difficult to replicate.

President and CEO of Momenta, Craig Wheeler said: "We continue to believe that the FDA engaged in a thorough review of the science supporting the Sandoz enoxaparin sodium injection ANDA, and are pleased that the Court re-affirmed the validity of the FDA's decision.